Clinical Research Associate II Specialist
2 weeks ago
Innovaderm is a specialized contract research organization (CRO) in the dermatology field. We have been providing high-quality research and services to our clients since 2000.
Job Title and SalaryClinical Research Associate II Specialist, $65,000 - $85,000 per year, depending on experience.
Job DescriptionThe Clinical Research Associate II Specialist will be responsible for monitoring clinical studies at investigative sites or remotely. This involves ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities:- Conduct site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines, and applicable regulations.
- Participate in investigators' meetings.
- Prepare site visit reports and follow-up letters to the investigator.
- Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
- Perform source data verification, ensure on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate.
- Bachelor's degree in a field relevant to clinical research, nursing degree, or equivalent experience.
- 2-5 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
- Experience in dermatology is an asset.
- Good knowledge of ICH/GCP standards and applicable regulatory requirements.
- Strong verbal and written communication skills in English.
- Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines.
- Permanent full-time position.
- Benefits package.
- 401K.
- Ongoing learning and development opportunities.
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